UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031150 |
|---|---|
| Receipt number | R000035580 |
| Scientific Title | The effects of amino acids mixture during exercise |
| Date of disclosure of the study information | 2018/02/24 |
| Last modified on | 2018/12/18 10:00:18 |
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Basic information
Public title
The effects of amino acids mixture during exercise
Acronym
The effects of amino acids mixture during exercise
Scientific Title
The effects of amino acids mixture during exercise
Scientific Title:Acronym
The effects of amino acids mixture during exercise
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of amino acid mixture with placebo during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire(VAS,RPE)
Key secondary outcomes
POMS2 Shortened version
Blood glucose
Lactate
Free fatty acid
Total ketone bodies
Cortisol
Amino acids
Physical measurement
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test product
-> Washout
-> Control product
Interventions/Control_2
Control product
-> Washout
-> Test product
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1)Subjects who have given written informed consent
2)Healthy males aged 30 to 59 years old
Key exclusion criteria
1) Subjects with food allergies
2) Subjects having a smoking habit
3) Subjects who had blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study
4)Subjects who participated in other clinical studies within one month or are currently participating in other clinical studies
5)Subjects who are judged as ineligible by the doctor for other reasons
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Yamaguchi |
Organization
Meiji Co., Ltd.
Division name
Food Science & Technology Research Labs, R&D Division
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
TEL
042-632-5849
makoto.yamaguchi@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sugino |
Organization
Soiken Inc.
Division name
Soiken Inc.
Zip code
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka 560-0082, Japan
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035580
